2014

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ATS Encourages Members to Submit Tobacco Comments to FDA

July 2014

The Food and Drug Administration has received nearly 20,000 comments from the public regarding the proposed regulatation of all tobacco products. Unfortunately, the vast majority of comments have come from cigar and e-cigarette consumers expressing opposition to FDA regulations. The voices of physicians and health care providers who treat patients with tobacco disease have largely been absent.

ATS members are encouraged to add their voice to the public comments. ATS members can go to www.regulatealltobacco.org and find key talking points to make to FDA and submit comments online.

The deadline for submitting comments is August 8, 2014.

The proposed rule would establish important basic regulatory authority over all tobacco products including:

  • Prohibiting the sales of tobacco products to anyone under the age of 18
  • Prohibiting vending machine sales (except in places where only adults have access)
  • Registration by all manufactures with FDA, including a list of all tobacco products they sell
  • Disclosure of ingredients by manufacturers to FDA
  • Elimination of free sampling of all tobacco products
  • Good manufacturing practice requirements
  • Premarket review for any "new" tobacco product
  • Premarket review of any product wishing to make a "modified risk or harm" claim
  • User fees for all newly deemed products

The proposed rule is also notable for what it does not address. The rule would not ban TV or radio advertising for newly deemed products. Cigarettes are currently banned from TV and radio advertising. While FDA is accepting comments on this issue, the proposed rule does not take any action to ban candy-flavored cigars, cigarillos or e-cigarettes.

FDA is also seeking public comments on whether "premium" cigars should be exempt from regulation. While FDA has proposed a more extensive definition, the exemption would apply to large hand-rolled cigars that to do not have a "characterizing" flavor other than tobacco.

In addition to encouraging individual member comments, the ATS will be submitting detailed comments on all aspects of the proposed rule and will urge the FDA to correct the shortcoming in the proposed rule.